Midazolam
- Product NDC
- 0409-2587
- 11-digit product format
- 004092587
- Labeler code
- 0409
- Product ID
- 0409-2587_6c075a2d-b68b-41a7-aa0c-bcf9894e3f76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MIDAZOLAM HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA075293
- Marketing category
- ANDA
- Marketing start
- 2006-02-02
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Midazolam
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIDAZOLAM HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W7TTW573JJ |
| Rxcui | 311700, 311702 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-2587-04 | Midazolam | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 31 |
| 0409-2587-05 | Midazolam | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 31 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MIDAZOLAM HYDROCHLORIDE | ACTIVE INGREDIENT | W7TTW573JJ | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| MIDAZOLAM | ACTIVE MOIETY | R60L0SM5BC | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-2587 | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 28 | Current NDC, Legacy NDC, 2 package rows | 20241220_affecd4d-1f78-4bbe-5a8d-86849bbdc520.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0409-2587-04 | 00409258704 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | | Historical |
| 0409-2587-05 | 00409258705 | 10 VIAL, MULTI-DOSE in 1 CARTON (0409-2587-05) / 10 mL in 1 VIAL, MULTI-DOSE (0409-2587-04) | | 2006-02-02 | 0000-00-00 | No | No | Current |